A Guide to FDA eSTAR Submission Template
What is eSTAR?
Starting October 1, 2023, all 510(k) submissions, unless exempt, are required to be electronically filed through eSTAR. This electronic system is specifically tailored as an interactive PDF document for assembling a comprehensive pre-market submission of medical devices intended for FDA 510(k) clearance within the United States. Additionally, eSTAR offers a resource for applicants to respond to FDA requests for supplementary information, enhancing the submission process. The primary goal behind eSTAR is to elevate the standard of submissions across diverse medical devices by ensuring submitters furnish thorough and top-notch data for the FDA’s pre-market review.
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Where Can I Access and Submit eSTAR for Pre-market Submission?
Accessing and utilizing eSTAR for a medical device submission involves several key steps:
- Download the eSTAR PDF Template: Obtain the eSTAR template from the FDA website, accessible under the eSTAR Program. Versions specific to medical devices and In Vitro Diagnostic devices are available for download.
- Prepare the Submission: Utilize the downloaded eSTAR submission template, which provides a standardized format inclusive of prompts, questions, and guidance. This standardized structure aids applicants in furnishing precise and comprehensive information required for the submission.
- Register for an Account: Access the CDRH Portal and register for an account. This registration is open to all individuals and facilitates the submission of CDRH eSTAR or eCopy pre-market submissions conveniently via an online platform.
- Submit the Application: Starting from October 1, 2023, ensure that all 510(k) submissions, except those that are exempt, are electronically submitted exclusively through eSTAR.
Guidance of eSTAR Submission Template
“Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” contains essential guidance regarding the development of templates for electronic submissions, which led to the creation of eSTAR submission template and could be used for creating proprietary templates. “Electronic Submission Template for Medical Device 510(k) Submissions” contains final FDA guidelines for electronic submissions, including exemptions for situations where users may not need to use eSTAR. Consulting these documents is an essential first step in determining whether and how users need to submit via eSTAR.
Online:
For CDRH, send eSTAR premarket submissions online through the CDRH Portal:
Send and Track Medical Device Premarket Submissions Online: CDRH Portal
For CBER, send eSTAR premarket submissions online through the FDA’s Electronic Submission Gateway (ESG) method. Instructions available at:
Regulated Submissions in Electronic and Paper Format for CBER-Regulated Products
By Mail:
eSTARs submitted by mail to CDRH’s Document Control Center (DCC) should be sent to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
eSTARs submitted by mail to CBER’s Document Control Center (DCC) should be sent to:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue – WO71, G112
Silver Spring, MD 20993-0002
eSTAR Submission Template
Explore the FDA eSTAR submission template thoroughly to understand each section’s information and format requirements. Fields in eSTAR become visible based on the choices you make, such as selecting submission types like Traditional, Abbreviated, or Special. By answering questions, additional fields tailored to your selection appear. Create a parallel template outside eSTAR to align and prepare the required information for a smoother submission process. This proactive approach ensures you gather and organize the necessary details efficiently.
What Is The Review Timeline For eSTAR?
The timeline for the various stages of the eSTAR submission process is outlined as follows:
- Refuse to Accept (RTA) Review: Completed within 15 days from the date of submission. During this phase, the FDA determines if the submission is complete and meets minimum requirements.
- Substantive Review: Carried out within 60 days following the RTA review. This phase involves a thorough assessment of the submission’s content and compliance with regulatory standards.
- Decision Letter: Issued within 90 days after the substantive review. The decision letter communicates the FDA’s decision regarding the clearance or approval status of the submission.
- Additional Information (AI) Requests: If the FDA requests additional documents or information, the submitter has 180 days to provide the requested materials from the date of the request.
If an eSTAR submission is incomplete upon filing, the FDA will notify the submitter via email regarding the missing information. The submission will be put on hold for 180 days or until a replacement eSTAR containing all the required information is submitted to the FDA.
Throughout the remainder of the 510(k) review process, the FDA follows its guidelines. Meanwhile, a De Novo classification request undergoes review as per 21 CFR p860, Subpart D, and aligns with the guidance provided by the FDA.
Benefits of Using eSTAR for Medical Device Submissions:
The eSTAR program offers several advantages that significantly impact the medical device submission process:
- Improved Transparency and Consistency: By providing a standardized format and a guided process, eSTAR ensures transparency and consistency in submissions. This standardized approach leads to increased completeness, streamlining the pre-market review process by the FDA. Consequently, it facilitates timely access to safe, effective, and high-quality medical devices.
- Enhanced Submission Quality: eSTAR dynamically generates relevant fields or sections based on initial responses, prompting submitters to provide comprehensive and high-quality data. This proactive approach significantly improves the quality of submissions, consequently enhancing the FDA’s pre-market review process.
- Streamlined Submission Process: Through an interactive PDF form, eSTAR simplifies the submission process, guiding applicants in creating comprehensive medical device submissions. This streamlining of procedures not only improves efficiency but can also reduce the time and resources needed for the clearance process.
- No e-Copy Validation Requirement: Unlike other submission methods, eSTAR does not mandate e-Copy validation, further simplifying the submission process for applicants.
How Operon Strategist Can Help You
Operon Strategist supports medical device manufacturers, startups, and importers with end-to-end FDA regulatory consulting services.
Our FDA Consulting Services Include
FDA 510(k) Submission Support
We help prepare and review complete FDA eSTAR submissions.
Regulatory Strategy Development
Our experts identify the correct FDA pathway and submission strategy.
Product Feasibility Assessment
We evaluate technical and regulatory feasibility before development.
Quality Management System Implementation
Support for ISO 13485 and FDA QMS compliance.
Product & Process Engineering
We help optimize manufacturing and compliance workflows.
Plant Layout Detail Engineering
Support for FDA-compliant manufacturing infrastructure planning.
Gap Assessment and Documentation
We identify missing documents and technical deficiencies before submission.
FAQ
Is FDA eSTAR mandatory for FDA 510(k) submissions?
Yes. Since October 1, 2023, eSTAR is mandatory for most FDA 510(k) submissions unless exempted.
What is the purpose of FDA eSTAR Submission?
FDA eSTAR standardizes medical device submissions and improves submission completeness for faster FDA review.
What documents are required for FDA eSTAR Submission?
Typical documents include:
- Device description
- Testing reports
- Labeling
- Risk management files
- Software validation
- Sterility validation
- Predicate comparison
How long does FDA eSTAR review take?
FDA typically performs:
- RTA review within 15 days
- Substantive review within 60 days
- Final decision around 90 days